Regulations
Recent U.S. Food and Drug Administration (FDA) approvals
Medtronic earns approval for Adaptive deep brain stimulation system; OrthoNovis gets clearance to market wrist fracture system
More in Regulations
Ferrocene becomes first Rust toolchain to achieve IEC 62304 qualification
Enables medical device developers to leverage the unmatched safety and reliability of Rust while streamlining compliance.
AdvaMed seeks medical technology exemption from all tariffs
The increased costs posed by tariffs, and their functioning essentially as an excise tax in practice, could resurrect the climate of concern the medical device excise tax created for nearly a decade.
The cost of non-compliance in medtech
To succeed in today’s medtech environment, companies must prioritize regulatory compliance and cybersecurity.
Best of 2024: #6 Article – Closing the global product information gap
Regulatory affairs can fuel clinical and quality teams with key product information, help speed time to market, and be a catalyst for innovation. But the truth is most medtechs aren’t seeing these benefits, slowed down by inefficient administrative tasks.
Learn to navigate the challenges of contracting with the Department of Defense
Webinar will illuminate the revenue-building opportunities in government contracting
Current regulatory news
MRPC completes ISO 13485:2016 recertification process
18 of the top 20 medtech companies partner with Veeva MedTech
More than 125 medtech customers use Veeva applications for seamless execution across product development and to get devices and diagnostics to patients faster.
Current regulatory news
FDA 510(k) clearance for miniature robotic system; ISO 13485 certification achieved for quality management system
A happy, restful Labor Day to all
Before it was a federal holiday, Labor Day was recognized by labor activists and individual states.
